CN104257410A - 进入与封闭装置和方法 - Google Patents

进入与封闭装置和方法 Download PDF

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CN104257410A
CN104257410A CN201410385081.1A CN201410385081A CN104257410A CN 104257410 A CN104257410 A CN 104257410A CN 201410385081 A CN201410385081 A CN 201410385081A CN 104257410 A CN104257410 A CN 104257410A
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lumen
arteriotomy
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D·布鲁斯·莫德西特
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Arstasis Inc
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Abstract

公开了用于进入和封闭脉管部位(114)的装置和方法。公开了自密封封闭装置(2)和方法。公开了一种可形成进入脉管管腔(114)的陡的且受控的进入路径的装置(2)。还公开了用于使用装置(2)的方法。

Description

进入与封闭装置和方法
本申请是申请日为2005年5月12日、申请号为200580023327.X、发明名称为“进入与封闭装置和方法”的申请的分案申请。
技术领域
本发明涉及进入生物管腔以及封闭由此生成的进入口的领域。
背景技术
目前可横穿管腔(translumenally)执行许多诊断和干涉脉管操作,其中在便于进入的位置例如股、臂或锁骨下动脉处将导管引入脉管系统,并引导其通过脉管系统到达目标位置以执行治疗或诊断。当不再需要脉管进入时,必须从脉管入口取出导管或其它脉管进入装置,并且必须在刺穿位置处止血。
一种通用的用于提供止血的方法是通常通过用手按压在刺穿位置附近或上游施加外力。此方法费时,常常在止血之前需要一个半小时或更长时间的按压。这一过程对于患者而言不舒服并且经常需要使用止痛剂。过大的压力还存在血管完全闭塞的危险,导致局部缺血和/或血栓形成。
在通过用手按压实现止血之前,患者需要保持斜躺6到18个小时进行观察,以确保持续止血。在此期间,从脉管进入处的出血可重新开始,有可能会导致严重的并发症。这些并发症可能需要输血和/或外科手术的介入。
还已经使用了可生物吸收的紧固件来止血。通常,这些方法依赖于形成血栓和生物可吸收的材料如骨胶原在刺穿位置的表面动脉壁上的放置。此方法通常难以确定叠置组织的界面和血管外膜表面的位置。距离预期位置过远植入紧固件会导致止血失败。但是,如果紧固件塞入脉管管腔,则会在紧固件上形成血栓。血栓会栓塞下游和/或阻塞血栓位置处的正常的血液流动。
还使用缝合技术在脉管进入之后实现止血。通过组织管道引入缝合实施装置,装置的远端位于脉管穿孔处。装置内的针拉动缝线穿过穿孔相对侧上的血管壁,并且在血管的外膜表面上直接固定缝线以封闭脉管进入伤口。
为获得成功,需要在精确控制下执行缝合方法。针需要被正确地引导穿过血管壁,以便可将缝线很好地固定在组织内以实现紧密闭合。缝合方法还需要另外的手术步骤。
由于上述方法和装置的不足,需要一种更可靠的脉管封闭方法和装置。还需要一种不会植入异物并且自密封的脉管封闭装置和方法。还需要一种不需要或需要很少的额外步骤以封闭脉管位置的脉管封闭装置和方法。
发明内容
公开了一种用于进入生物管腔的装置。生物管腔具有管腔壁,所述管腔壁具有纵向管腔壁轴线。所述装置具有细长部件,所述细长部件具有纵向部件轴线。所述部件构造成以第一角度进入管腔。第一角度通过纵向管腔壁轴线和纵向部件轴线限定。第一角度小于大约19度。
有利地,第一角度可小于大约15度。有利地,第一角度可小于大约10度。有利地,所述第一角度大于大约5度。有利地,所述装置还具有锚杆(anchor)。有利地,锚杆可构造成保持细长部件相对于纵向管腔壁轴线成固定角度。
有利地,所述装置还可具有保持件。有利地,保持件可构造成保持细长部件相对于纵向管腔轴线成固定角度。
公开了另一种用于进入生物管腔的装置。生物管腔具有管腔壁和纵向管腔壁轴线。所述装置具有第一细长部件和第二细长部件。第一细长部件具有第一细长部件轴线。第二细长部件具有第二细长部件轴线。第二细长部件构造成使得第二细长部件轴线平行于纵向管腔壁轴线。
有利地,第二细长部件可具有保持件。有利地,所述保持件可具有可充气部件。有利地,所述保持件可具有弹性部件。有利地,第二细长部件可基本上靠近管腔壁延伸。
还公开了一种用于封闭生物管腔壁上的开口的装置。所述装置具有纵向轴线、第一施力部件、第二施力部件和弹性部件。弹性部件向第一和第二施力部件提供相对于纵向轴线沿径向向外的力。
有利地,所述第一施力部件沿第一方向施加力,所述第二施力部件沿第二方向施加力,并且所述第一方向基本上与所述第二方向相反。
还公开了一种穿过血管壁进入血管的方法。所述血管壁具有纵向壁轴线。所述方法包括相对于纵向壁轴线以小于大约19度的角度进入血管。所述方法还包括将管腔工具插入血管。
有利地,所述第一角度小于大约10度。有利地,所述第一角度小于大约15度。有利地,所述第一角度大于大约5度。有利地,所述方法还包括在进入之前使一装置与管腔壁成一直线。
还公开了一种用于进入生物管腔的方法。所述生物管腔具有管腔壁和纵向管腔壁轴线。所述方法包括将第二细长部件插入生物管腔。所述第二细长部件具有第二细长部件轴线。所述方法还包括调整所述第二细长部件,使得第二细长部件轴线基本上平行于纵向管腔壁轴线。此外,所述方法包括将具有第一细长部件轴线的第一细长部件插入生物管腔。
有利地,所述第一细长部件轴线和纵向管腔壁轴线之间的角度小于大约15度。有利地,所述第一细长部件轴线和纵向管腔壁轴线之间的角度小于大约10度。有利地,所述第二细长部件包括保持件,所述方法还包括延伸所述保持件。有利地,所述保持件包括弹性部件。有利地,所述第二细长部件包括可充气部件,所述方法还包括为所述可充气部件充气。有利地,所述第二细长部件基本上靠近管腔壁延伸。
另外,公开了一种封闭脉管开口的方法。所述脉管开口具有内表面和纵向轴线。所述方法包括在所述开口内插入一装置并向内表面施加力。所述力沿至少一个从纵向轴线径向向外的方向。
有利地,所述方法可包括保持所述力。有利地,所述保持包括保持小于大约120分钟。有利地,施加力可包括所述装置施加所述力的至少一部分。有利地,施加力可包括所述装置施加全部力。
还公开了一种用于进入和封闭具有血管壁的血管的方法。所述血管壁可具有内表面和外表面。所述方法包括形成动脉切口并在动脉切口内布置封闭增强装置。所述封闭增强装置在内表面和外表面上产生压力。
有利地,所述封闭增强装置包括细丝,并且所述细丝在所述动脉切口内。有利地,所述封闭增强装置包括压力夹。有利地,所述封闭增强装置包括小拭子。有利地,所述封闭增强装置包括紧线钳。有利地,所述封闭增强装置包括缝线。
还公开了一种用于进入具有血管壁的血管的方法,其中所述血管壁具有内表面和外表面,所述方法包括:
在血管壁内形成动脉切口,其中所述动脉切口具有动脉切口行程和动脉切口高度,并且动脉切口高度大约等于或小于动脉切口行程的三分之一,以及
穿过所述动脉切口布置脉管工具。
有利地,形成动脉切口还包括穿过血管壁布置导入装置,并且所述导入装置相对于血管壁基本上以各种角度经过血管壁。
有利地,形成动脉切口还包括穿过血管壁布置导入装置,并且所述导入装置在管腔壁内切出一平面。
有利地,所述平面可基本上平行于管腔壁。
有利地,血管壁具有外膜,并且所述平面与外膜相邻。
有利地,所述动脉切口具有外部管腔壁开口和内部管腔壁开口,并且导入行程为在所述外部管腔壁开口和所述内部管腔壁开口之间的基本上平行于管腔壁的长度的分量。
有利地,导入高度为在所述外部管腔壁开口和所述内部管腔壁开口之间的基本上垂直于管腔壁的长度的分量。
有利地,所述动脉切口高度大约等于或小于动脉切口行程的四分之一。
有利地,所述动脉切口高度大约等于或小于动脉切口行程的五分之一。
还公开了一种用于进入具有血管壁的血管的方法,其中该血管壁具有内侧和外侧,所述方法包括:
布置导入装置以形成动脉切口,
相对于血管壁以第一角度移动导入装置穿过血管壁,
相对于血管壁以第二角度移动导入装置穿过血管壁,以及
利用导入装置进入血管壁内侧。
有利地,所述第一角度或第二角度小于大约5度。
有利地,所述第一角度或第二角度为大约0度。
有利地,所述导入装置在血管壁的外侧上形成外部开口,所述导入装置在血管壁的内侧上形成内部开口,所述内部开口和外部开口之间的向量可包括导入行程和导入高度,导入高度与导入行程的比率可等于或小于大约1/2。
有利地,所述导入高度与导入行程的比率可等于或小于大约1/3。
有利地,所述导入高度与导入行程的比率可等于或小于大约1/4。
有利地,所述导入高度与导入行程的比率可等于或小于大约1/5。
有利地,所述导入高度与导入行程的比率可等于或小于大约1/6。
附图说明
图1是动脉切口装置的实施例的正面透视图;
图2是图1的动脉切口装置的侧视图;
图3是图1的动脉切口装置的局部放大图;
图4和5是锚杆的不同实施例的局部放大图;
图6是布置有导入装置的动脉切口装置的实施例的侧面透视图;
图7是布置有导入装置的动脉切口装置的实施例的局部放大图;
图8和9是布置有导入装置的动脉切口装置的不同实施例的侧视图;
图10是动脉切口装置的实施例的底部透视图;
图11是布置有管腔保持件的动脉切口装置的实施例的侧视图;
图12是布置有管腔保持件的动脉切口装置的实施例的底部透视图;
图13是动脉切口装置的实施例的侧面透视图;
图14是布置有入口壁保持件的动脉切口装置的实施例的侧面透视图;
图15和16示出张紧器的不同实施例;
图17和18示出压力夹的不同实施例;
图19和20示出紧线钳(toggle)的不同实施例;
图21示出用于在管腔的横截面内布置动脉切口装置的方法;
图22和23示出用于在管腔的横截面内布置保持件的方法;
图24和25示出用于在管腔的横截面内布置导入装置的方法;
图26示出用于在管腔的横截面内布置导线的方法;
图27-30示出用于在管腔的横截面内布置导入装置的方法;
图31示出用于在管腔的横截面内布置导线的方法;
图32示出形成有动脉切口的管腔的一部分;
图33示出图28的剖面A-A;
图34-36示出用于在管腔壁的透明部分内布置张紧器的方法;
图37-40示出用于在管腔的横截面内布置压力夹的不同实施例的方法;图41示出在形成有动脉切口的管腔的一部分上使用缝线的方法;
图42示出具有剖面外缝线的图41的剖面B-B;
图43示出在形成有动脉切口的管腔的一部分上使用小拭子的方法;
图44示出图43的剖面C-C;
图45示出处于第一构型的紧线钳布置装置的实施例;
图46是图45的局部放大图;
图47示出处于第二构型的紧线钳布置装置的实施例;
图48是图47的局部放大图;
图49示出在管腔的横截面内使用紧线钳布置装置的方法;
图50示出其中以剖面D-D示出紧线钳布置装置的一部分的图49;
图51示出在管腔的横截面内使用紧线钳布置装置的方法;
图52示出其中以剖面E-E示出紧线钳布置装置的一部分的图51;
图53-55示出在管腔的横截面内使用紧线钳布置装置的方法;
图56是图55的局部放大图;
图57示出布置于管腔的横截面内的紧线钳的实施例;
图58是图57的局部放大图;
图59-61示出用于在管腔的横截面内布置紧线钳的方法;
图62是图61的局部放大图;
图63示出用于在管腔的横截面内布置紧线钳的方法;
图64-66以剖面示出用于穿过动脉切口布置导线的方法;
图67和68示出用于将导线连接到锚杆上的方法。
具体实施方式
图1到3示出用于进入生物管腔的装置,例如动脉切口装置2。动脉切口装置2可具有输送导向件4。输送导向件4可滑动地连接在锚杆(anchor)6上。锚杆6可以为刚性的、柔性的或它们的组合。锚杆6可以为弹性的、可变形的或它们的组合。锚杆6可从输送导向件4缩回和伸出。输送导向件4可具有导引器管腔8。导引器管腔8可具有导引器管腔出口10。导引器管腔出口10可位于输送导向件4的表面上。
锚杆6可具有锚杆弯角部分12。锚杆6可具有锚杆延伸部分14,例如导眼(guide eye)护套或可附装的导线。锚杆延伸部分14可从锚杆弯角部分12延伸出。锚杆延伸部分14可与锚杆弯角部分12分离并可连接到锚杆弯角部分12上,或者与其成一体。
锚杆弯角部分12可具有锚杆弯角第一子部分16、锚杆弯曲部20和锚杆弯角第二子部分18。锚杆弯角第一子部分16和/或第二子部分18可以是锚杆弯曲部20的一部分。锚杆弯曲部20可具有尖锐的或平缓的曲线。锚杆弯曲部20的曲率半径可从大约0.1mm(0.004英寸)到大约2.0mm(0.079英寸)。
锚杆弯角第一子部分16可具有从大约0.38mm(0.015英寸)到大约1.0mm(0.039英寸)、例如大约0.71mm(0.028英寸)的锚杆弯角第一子部分直径22。锚杆弯角第二子部分18可具有从大约0.38mm(0.015英寸)到大约1.0mm(0.039英寸)、例如大约0.71mm(0.028英寸)的锚杆弯角第二子部分直径24。
锚杆弯角第一子部分16具有输送纵向轴线26。锚杆弯角第二子部分18具有锚杆纵向轴线28。输送纵向轴线26与锚杆纵向轴线28的交叉点为锚固角度30。锚固角度30可从大约20°到大约90°,更窄地从大约30°到大约60°,例如大约45°。
动脉切口装置2的任何或所有部件或者文中所述的其它装置或设备可由例如一种或多种不锈钢合金、镍钛合金(例如Nitinol)、钴铬合金(例如,Elgin Specialty Metals,Elgin,IL的Carpenter MetalsCorp.,Wyomissing,PA的)、钼合金(例如钼TZM合金,例如如2003年10月9日公开的国际出版物No.WO 03/082363 A2内所公开的,该出版物在此整体引入作为参考)、钨铼合金——例如国际出版物No.WO 03/082363内所公开的、聚合物例如聚酯(例如E.I.Du Pontde Nemours and Company,Wilmington,DE的)、聚丙烯、聚四氟乙烯(PTFE)、膨胀PTFE(ePTFE)、聚醚醚酮(PEEK)、尼龙、聚醚嵌段共聚酰胺聚合物(例如ATOFINA,Paris,France的)、脂族聚醚型荆氨酯(例如Thermedics Polymer Products,Wilmington,MA的)、聚氯乙烯(PVC)、聚氨酯、热塑性塑料、氟化乙烯丙烯(FEP)、可吸收或再吸收聚合物例如聚乙醇酸(PGA)、聚乳酸(PLA)、聚对二氧环己酮、和假聚胺酪氨酸基酸(pseudo-polyamino tyrosine-based acid)、压延胶原、硅酮、锌、回声(echogenic)、放射性、不透射线材料或它们的组合制成。不透射线材料的示例为硫酸钡、氧化锌、钛、不锈钢、镍钛合金、钽和金。
动脉切口装置2的任何或所有部件——包括辅助封闭装置例如张紧器、夹钳、紧线钳、缝线或文中所述的其它装置或设备——可以是或具有用于细胞向内生长的基质,或与织物例如用作细胞向内生长的基质的覆盖物(未示出)一起使用。基质和/或织物可以是例如聚合物(例如E.I.du Pontde Nemours and Company,Wilmington,DE的)、聚丙烯、PTFE、ePTFE、尼龙、压延胶原、硅酮或它们的组合。
动脉切口装置2的部件和/或织物可用本领域普通技术人员已知的药剂输送基质和/或治疗和/或诊断剂填充和/或覆盖。这些基质内的药剂可包括放射性材料;不透射线材料;细胞形成剂;细胞毒素剂;细胞生长抑制剂;血栓形成剂,例如聚氨酯、与三氧化二铋混合的醋酸纤维素聚合物和乙烯-乙烯基醇;不稳定、亲水材料;phosphor cholene;消炎剂,例如非甾族消炎剂(NSAIDs)如环加氧酶-1(COX-1)抑制剂(例如,乙酰水杨酸,例如Bayer AG,Leverkusen,Germany的布洛芬,例如Wyeth,Collegeville,PA的消炎痛;扑湿痛)、COX-2抑制剂(例如,Merck&Co.,Inc.,Whitehouse Station,NJ的Pharmacia Corp.,Peapack,NJ的COX-1抑制剂);免疫抑制剂,例如Sirolimus(Wyeth,Collegeville,PA的),或者较早地用于炎症反应途径的基质金属蛋白(MMP)抑制剂(例如,四环素和四环素衍生物)。Walton et al,Inhibition of Prostoglandin E2Synthesis in Abdominal Aortic Aneurysms,Circulation,1999年7月6日,第48-54页;Tambiah et al,Provocation of Experimental AorticInflammation Mediators and Chlamydia Pneumoniae,Brit.J.Surgery 88(7),第935-940页;Franklin et al,Uptake of Tetracycline by AorticAneurysm Wall and Its Effect on Inflammation and Proteolysis,Brit.J.Surgery 86(6),第771-775页;Xu et al,Sp1 Increases Expression ofCyclooxygenase-2in Hypoxic Vascular Endothelium,J.BiologicalChemistry275(32),第24583-24589页;以及Pyo et al,Targeted GeneDisruption of Matrix Metalloproteinase-9(Gelatinase B)SuppressesDevelopment of Experimental Abdominal Aortic Aneurysms,J.ClinicalInvestigation105(11),第1641-1649页中给出了其它药剂的示例,这些文章整体引入作为参考。
图4示出锚杆弯角部分12和锚杆延伸部分14可具有柔性细长部件。柔性细长部件可为有弹性的和/或可变形的。柔性细长部件可具有成一体的、或多个分离的且固定连接的缠绕线32。锚杆弯角部分12可位于护套34内。图5示出锚杆弯角部分12可具有线涂层36,例如润滑涂层和/或由聚氨脂制成的涂层。
图6和7示出动脉切口装置2可具有导入装置38。导入装置38可滑动地连接在导引器管腔8上。导入装置38可具有空心针(如图6所示)。导入装置38可具有实心针(如图7所示)。导入装置38可具有导线。
导入装置38可具有导入纵向轴线40。导入纵向轴线40与锚杆纵向轴线28的交叉点为导入角42。导入角42可小于或等于大约19°,更窄地小于或等于大约15°,更窄地从大约5°到大约10°,例如大约10°。
导入装置38可具有导入装置直径44。导入装置直径44可从大约0.25mm(0.010英寸)到大约1.0mm(0.039英寸),例如大约0.56mm(0.022英寸)。
图8和9示出动脉切口装置2可构造成使得可从锚杆6布置导入装置38。锚杆6可具有导入装置口46。导入装置38可以是空心针(如图8所示)。当完全展开时,导入装置38可接触导引器管腔出口10。导入装置38可以是导引器管腔8和锚杆6之间的通道。锚杆6可具有构造成与生物管腔和导入装置38相连通的孔口(未示出)。导入装置38可为实心针(如图9所示)。
图10示出管腔保持件48可具有第一缩回构型。管腔保持件48可安装在管腔保持件口50内。管腔保持件口50可位于锚杆6内。管腔保持件48可以是线、支架或展伸件——例如由可变形或弹性材料如形状记忆合金制成、充气式囊、或它们的组合。管腔内充气式囊例如用盐溶液或二氧化碳充气的囊是本领域普通技术人员已知的。管腔保持件48可延伸进输送导向件4内。
图11和12示出管腔保持件48可具有第二展开构型。图11示出管腔保持件48可以是线或囊。图12示出管腔保持件48可以是线。在该展开构型中,管腔保持件48可远离管腔保持件口展开。管腔保持件48可具有管腔保持件展开直径52。管腔保持件展开直径52可从大约2.54mm(0.100英寸)到大约10.2mm(0.400英寸),例如大约6.35mm(0.250英寸)。
图13示出动脉切口装置2可具有入口壁保持件口54。入口壁保持件口54可位于或靠近锚杆弯曲部20。入口壁保持件口54可位于或靠近锚杆弯角第一子部分16。入口壁保持件口54可与位于或靠近动脉切口装置2的输送导向件4的传感器或端口(未示出)流体连通。
图14示出可穿过入口壁保持件口54布置入口壁保持件56。入口壁保持件56可具有第一缩回构型(如图13所示)。入口壁保持件56可具有第二展开构型(如图14所示)。
图15到20示出各种辅助封闭装置。辅助封闭装置可完全地或部分地生物可吸收、生物再吸收、生物可吸附或它们的组合。辅助封闭装置可由同种移植物、异种移植物或它们的组合制成。辅助封闭装置可由自体移植物、同种异体移植物或它们的组合制成。
图15示出一张紧器58。张紧器58可为弹性的、可变形的或它们的组合。张紧器58可具有张紧器纵向轴线60。张紧器58可具有弹性部件如弹簧,例如张紧器头部62。张紧器头部62可具有张紧器第一肩部64。张紧器头部62可具有张紧器第二肩部66。张紧器第一肩部64和第二肩部66分别可转动地连接到分离的或成一体的张紧器第一支腿68和分离的或成一体的张紧器第二支腿70。张紧器第一支腿68和第二支腿70可分别连接到张紧器第一脚部72和第二脚部74。
张紧器支腿68和70可具有张紧器支腿直径76。张紧器支腿直径76可为从大约0.1mm(0.005英寸)到大约0.76mm(0.030英寸),例如为大约0.38mm(0.015英寸)。张紧器第一支腿68和第二支腿70可具有张紧器支腿间外径78。张紧器支腿间外径78可为从大约1.3mm(0.050英寸)到大约5.08mm(0.200英寸),例如为大约4.06mm(0.160英寸)。张紧器肩部64和/或66和/或张紧器脚部72和/或74从张紧器纵向轴线60延伸的距离可大于它们各自的张紧器支腿间半径。
图16示出可连接到张紧器第一支腿68和张紧器第二支腿70的张紧器第一支杆80。张紧器第一支腿68可以是弹性的、可变形的或它们的组合。张紧器第二支杆82可连接到张紧器第一支腿68和张紧器第二支腿70。张紧器第二支腿70可为弹性的和/或可变形的。张紧器58可不具有张紧器头部62。张紧器58可具有多于两个的张紧器支杆80和82。
图17示出压力夹84。压力夹84可为弹性的。压力夹84可为可变形的。压力夹84可具有压力夹纵向轴线86。压力夹84可具有压力夹头部88。压力夹头部88可转动地连接到分离的或成一体的压力夹第一支腿90。压力夹头部88可转动地连接到分离的或成一体的压力夹第二支腿92。压力夹可具有压力夹第一端部94和压力夹第二端部96。压力夹第一支腿90可在压力夹第一端部94处终止。压力夹第二支腿92可在压力夹第二端部96处终止。压力夹第一支腿90和/或压力夹第二支腿92可朝压力夹纵向轴线86被偏压。
图18示出可具有可滑动地附装到压力夹第二支腿92上的压力夹护套98的压力夹84。压力夹第一端部94和/或第二端部96可以是压力分散器如扁平和/或弯曲部分,例如圆环。压力夹第一端部94和/或第二端部96可为弹性的和/或可变形的。压力夹第一支腿90可转动地连接到压力夹第二支腿92。压力夹第一支腿90可经由压力夹头部88中的可转动的和/或可变形的和/或挠性的接头连接到压力夹第二支腿92。
图19示出紧线钳100。紧线钳100可具有紧线钳第一端部102。紧线钳100可具有紧线钳第二端部104。紧线钳第一端部102和/或第二端部104可以是棒、销、杆、梁或它们的组合。紧线钳100可具有细丝106。细丝106可在细丝第一端部107固定地连接到紧线钳第一端部102。细丝106可在细丝第二端部109固定地连接到紧线钳第二端部104。细丝106可为弹性的或可变形的。细丝106可基本上为柔性的。
图20示出可具有细丝106的紧线钳100,该细丝可在孔108处可滑动地连接到紧线钳第二端部104。细丝106可与孔108摩擦配合。细丝106可不具有棘爪110(图20中未示出)。细丝106可与孔108干涉配合。细丝106可具有一个或多个棘爪110。孔108可具有一个或多个槽口112。槽口112可在孔108的内部。槽口112和棘爪110可构造成使得紧线钳第二端部104可以朝紧线钳第一端部102滑动。槽口112和棘爪110可构造成在紧线钳第二端部104试图移离紧线钳第一端部102时提供干涉配合。
制造方法
动脉切口装置2的部件——包括辅助封闭装置——可通过例如熔融、旋拧、粘接、焊接或使用干涉配合或压力配合如压接、咬合或它们的组合方法直接附装。部件可用单一构件或材料成一体地例如模制、冲切、激光切割、放电加工(EDM)或冲压。可使用本领域普通技术人员已知的任何其它方法。
成一体的部件可由本领域普通技术人员已知的被预成型并被偏压成后期展开形状(post-deployment shape)然后被压缩成展开形状(deploymentshape)的预成型弹性材料——例如弹性合金(例如Nitinol、)——制成。
动脉切口装置2的任何部件(包括辅助封闭装置)或组装后作为一个整体的动脉切口装置2(包括辅助封闭装置)可使用本领域普通技术人员已知的浸涂、刷涂或喷涂方法进行涂敷。例如,可使用这些方法涂敷缠绕线32,其中线涂层36可被喷涂、浸涂或刷涂到缠绕线32上。
Ding et al的美国专利No.6358556提供了用于涂敷血管用医疗装置的方法的一个示例,该专利在此整体引入作为参考。本领域普通技术人员已知的延时释放涂敷方法还可用于延迟涂层——例如辅助封闭装置上的涂层——内的药剂的释放。
辅助封闭装置可覆盖有织物,例如聚合物(例如E.I.du Pont deNemours and Company,Wilmington,DE的)、聚丙烯、PTFE、ePTFE、尼龙、压延胶原、硅酮或它们的组合。用织物覆盖可植入装置的方法是本领域普通技术人员已知的。
使用方法
图21示出将锚杆6插入生物管腔114例如血管如股动脉的方法。生物管腔114可具有管腔壁116和管腔壁表面118。可使用Seldinger技术、改进的Seldinger技术或本领域技术人员已知的其它方法将锚杆6插入生物管腔114。锚杆6可形成第一动脉切口120。可将锚杆6插入管腔114以使得锚杆弯角第二子部分18可基本平行于管腔壁表面118。可将锚杆6插入管腔114以使得锚杆弯角第二子部分18可基本与管腔壁表面118接触。
图22示出如箭头所示将管腔保持件48从第一缩回构型展开到第二展开构型的方法。管腔保持件48可通过伸出线、支架或展伸件或通过给囊充气来展开。当管腔保持件48展开时,可使锚杆弯角第二子部分18基本平行于管腔壁表面118。当管腔保持件48展开时,可使锚杆弯角第二子部分18基本与管腔壁表面118接触。
图23示出如箭头122所示使入口壁保持件56从第一缩回构型展开到第二展开构型的方法。当管腔保持件处于第二展开构型时,管腔保持件48可基本平行于管腔壁表面118。当管腔保持件处于第二展开构型时,管腔保持件48可基本与管腔壁表面118接触。
如箭头124所示,例如可通过将近端力施加给输送导向件4而将近端力施加给锚杆6。当施加近端力时,可使锚杆弯角第二子部分18基本平行于管腔壁表面118。当施加近端力时,可使锚杆弯角第二子部分18基本与管腔壁表面118接触。
图24和25示出用于布置导入装置38的方法。导入装置38可从导引器管腔8和导引器管腔出口10伸出。如图24所示,可如箭头所示将导入装置38推入并穿过管腔壁116。导入装置38可形成第二动脉切口128。如图25所示,可如箭头所示将导入装置38推到锚杆6附近或穿过锚杆6。锚杆6可构造成具有适合于导入装置38经过锚杆6的孔口。导入装置38的尖端可进入管腔114。
导入装置38可经过一导入行程132和一导入高度134。导入行程132可以是导入装置38在管腔壁116中的长度的平行于管腔壁116的分量。导入行程132可以是在第二动脉切口128在管腔壁116外侧的开口和第二动脉切口128在内侧管腔壁表面118的开口之间的长度的平行于管腔壁116的分量。导入行程132可从大约0.10cm(0.010英寸)到大约3.810cm(1.500英寸),例如大约0.64cm(0.25英寸)。
导入高度134可以是导入装置38在管腔壁116中的长度的垂直于管腔壁116的分量。导入高度134可以是在第二动脉切口128在管腔壁116外侧的开口和第二动脉切口128在内侧管腔壁表面118的开口之间的长度的垂直于管腔壁116的分量。导入高度134可从大约0.51mm(0.020英寸)到大约5.08mm(0.200英寸),例如大约1.0mm(0.040英寸)。导入斜度是导入高度134与导入行程132的比率。导入斜度可以从大约1/2到大约1/40或更小,例如大约1/6,还例如为大约1/3。导入斜度例如可以等于或小于1/2或1/3,更窄地等于或小于大约1/3或1/4,更窄地等于或小于大约1/5或1/6,还更窄地等于或小于大约1/10。
导入高度134和导入行程132可以是一导入向量的分量。导入行程132可以是该导入向量的平行于管腔壁116的分量。导入高度134可以是该导入向量的垂直于管腔壁116的分量。导入向量可以是从外部开口136到内部开口138的向量。外部开口136可以是由导入装置38形成的在管腔壁116外侧的临时或永久开口。内部开口138可以是血管壁内侧的临时或永久开口。
图26示出导入装置38(例如空心针)可用作如箭头所示被布置到管腔114内的管腔工具(例如导线168)的通路。可从第二动脉切口128取出导入装置38例如实心针,并且可通过例如导引器管腔出口10和第二动脉切口128布置管腔工具。导入装置38可以是管腔工具,例如导线。导入装置38还可进一步展开并且在经过管腔壁116之后用作管腔工具。
图27到30示出布置具有预成型的弯曲部的导入装置38的方法。如图27所示,动脉切口装置2可构造成以从大约0°到大约5°、例如大约0°的导入角42布置导入装置38。
如图28所示,可如箭头所示推动导入装置38穿过管腔壁116。导入装置38可在管腔壁116内切出一平面。该平面可基本上平行于管腔壁表面118。导入装置38可与血管内的外膜相邻。导入装置38可沿血管中的内膜下或中线下(submedial)的切开平面前进。一旦管腔壁已被切开,则可执行本领域普通技术人员已知的内膜下血管成形术。一旦管腔壁已被切开,则可执行本领域普通技术人员已知的远程动脉内膜切除术。弯曲的和直的导入装置38可在使用期间交换以选择性地切开管腔壁116。可穿过空心导入装置38将工具例如导线插入以选择性地切开管腔壁116。
如图29所示,当导入装置38内的弯曲部移进管腔壁116内时,导入装置38可如箭头所示朝生物管腔114转动。如图30所示,导入装置38内的弯曲部可继续使导入装置38朝生物管腔114转动。如下文所述,导入装置38可进入管腔114。图31示出具有弯曲部的导入装置38可如下文所述用作管腔工具的通路。
可将一导引器护套插在导线168和/或导入装置38上。导引器护套可小于大约22French(直径为7.3mm,0.29英寸)或小于导引器护套将被导入其中的管腔的直径。导引器护套可为例如大约6French(直径为2.3mm,0.092英寸),以及大约8 French(直径为2.67mm,0.105英寸)。导引器护套可为本领域普通技术人员已知的,例如Dubrul,et al.的美国专利No.5183464中所述的导引器护套。
可将导引器护套插入第二动脉切口128。导引器护套可将第二动脉切口128扩展到可操作的尺寸。可在布置辅助封闭装置和/或使用其它封闭方法之前和/或之后和/或同时将导引器护套插入第二动脉切口128。
图32和33示出在动脉切口装置2已被布置到生物管腔114以及从该生物管腔去除之后的示例性生物管腔114。生物管腔114可具有第一动脉切口120和第二动脉切口128。生物管腔114可具有第二动脉切口128。生物管腔114可在动脉切口(示出为第二动脉切口128)的一侧具有第一膜/网(web)140,而在动脉切口120或128的相对侧上具有第二膜142。来自第一膜140和第二膜142的如箭头所示的自然压力可自密封动脉切口120或128。
可为第一动脉切口120和/或第二动脉切口128配置一个或多个辅助封闭装置。辅助封闭装置可提供力或约束以帮助止血。辅助封闭装置可永久地或临时地配置。辅助封闭装置可在实现止血之后和/或在相关的动脉切口120或128基本上或完全愈合之后生物溶解(biodissolve)。来自辅助封闭装置的力可保持从大约15分钟到大约24小时或更长时间,例如大约120分钟。
图34示出处于压缩构型的张紧器58。如箭头所示的压缩力可压缩张紧器第一支腿68和第二支腿70。在压缩构型中,张紧器支腿间外径78可从大约0.51mm(0.020英寸)到大约2.54mm(0.100英寸),例如为大约1.5mm(0.060英寸)。
图35和36示出布置张紧器58的方法。如图35所示,张紧器58可处于压缩构型。张紧器58可暴露在如箭头144所示的压缩力下。可通过可缩回的护套、夹具或本领域普通技术人员已知的其它方法或它们的组合施加压缩力。如箭头146所示的展开力可将张紧器58布置到动脉切口120或128内。
动脉切口120或128可具有动脉切口直径148。动脉切口直径148可从大约0.5mm(0.020英寸)到大约400mm(15英寸),较窄的范围为从大约1.0mm(0.040英寸)到大约10.2mm(0.400英寸),例如为大约2.54mm(0.100英寸)。当处于压缩构型时,张紧器支腿间外径78可小于动脉切口直径148。张紧器第一肩部64和第二肩部66可足够宽以与动脉切口120或128干涉配合。张紧器第一肩部64和第二肩部66可分散管腔壁表面118上的力。
如图36所示,可从张紧器58去除压缩力。张紧器第一支腿68和第二支腿70可如箭头所示张开。张紧器58可将动脉切口120或128压成基本上或完全是平的和/或闭合的和/或拉紧的构型。动脉切口120或128的壁可紧密接触。
动脉切口120或128可具有动脉切口宽度150和动脉切口高度152。动脉切口宽度150可大约为动脉切口120或128的周长的一半。动脉切口宽度150可为从大约1.0mm(0.040英寸)到大约10.2mm(0.400英寸),例如为大约4.06mm(0.160英寸)。
动脉切口高度152可大约为张紧器支腿直径76。动脉切口高度152可小于大约0.51mm(0.020英寸),更窄地小于大约0.38mm(0.015英寸)。动脉切口高度152可为从大约0.25mm(0.010英寸)到大约1.3mm(0.050英寸),例如为大约0.38mm(0.015英寸)。动脉切口高度152可足够小以使得能够越过动脉切口120或128(实现)细胞生长、血液凝固、声密封、热密封、粘接、提高的自密封以及它们的组合。
张紧器第一肩部64和第二肩部66可足够宽以与动脉切口120或128干涉配合。张紧器第一脚部72和第二脚部74可足够宽以与动脉切口120或128干涉配合。张紧器第一脚部72和第二脚部74可分散管腔壁表面118上的力。
可在使用下文和/或前文所述的任何辅助封闭装置、自密封封闭方法或它们的组合之前和/或同时和/或之后堵塞和/或包扎和/或用止血塞塞住动脉切口120或128。塞子、裹布(pack)、止血塞或它们的组合(未示出)可由明胶海绵、骨胶原、本领域内的普通技术人员已知的其它可植入以及可生物相容的止血塞材料或它们的组合制成。
图37到40示出将压力夹84布置到动脉切口120或128。图37示出延伸和/或弄细和/或弄直和/或张紧压力夹第二端部96。压力夹护套98可如箭头所示沿压力夹第二支腿92平移并平移到压力夹第二端部96上。可在压力夹第二端部96被延伸和/或弄细和/或弄直和/或张紧之后将压力夹84布置到动脉切口。
如图38所示,可相对于压力夹头部88转动压力夹第二支腿92,使得压力夹第二支腿92和压力夹头部88基本上成一直线。可如箭头所示通过第一动脉切口120布置压力夹第二支腿92。可通过管腔壁116布置压力夹第二支腿92(例如,如果不存在第一动脉切口120;如果第一动脉切口120没有相对于第二动脉切口128适当地定位)。
图39示出缩回和/或展宽和/或释放和/或放松压力夹第二端部96。压力夹护套98可如箭头所示沿压力夹第二支腿92平移并移离压力夹第二端部96。可在将压力夹84布置到动脉切口之后缩回和/或展宽和/或释放和/或放松压力夹第二端部96。
如图40所示,在通过第一动脉切口120布置压力夹第二支腿92之后,可释放压力夹第二支腿92或使其变形以便相对于压力夹头部88转动。压力夹头部88可安放在第一动脉切口120内。压力夹第一支腿90和第二支腿92可如箭头所示分别向第一膜140和第二膜142施加力。
图41和42示出围绕和/或穿过动脉切口120或128布置缝线154的方法。缝线154可被拉紧以向动脉切口120或128施加额外的压力。缝线154可具有结156或其它打结构造或装置,例如小拭子或夹具。
图43和44示出靠近和/或穿过动脉切口120或128布置细丝106的方法。细丝106可通过第一结156a或其它打结构造或装置连接到第一小拭子158a。细丝106可通过第二结156b或其它打结构造或装置连接到第二小拭子158b。第一小拭子158a和第二小拭子158b可以是本领域内的普通技术人员已知的其它压力扩散器(diffuser),例如前文以及下文所述的紧线钳100。
图45和46示出处于第一缩回构型的紧线钳布置装置159。紧线钳布置装置159可具有压力检查口160。压力检查口160可与紧线钳布置装置159例如一外部管腔的手柄(未示出)之上或附近的传感器或端口流体连通,在该装置中可例如从来自外部管或端口的端部的流动和/或通过透明或半透明窗口观察到血流。压力检查口160可有助于将紧线钳布置装置159布置到压力检查口160被引入压力的位置,例如当压力检查口160进入生物管腔114时。紧线钳布置装置159上或附近的传感器或端口可用信号通知压力检查口160已被放置到生物管腔114内(例如通过显示少量的血流)。可将压力检查口160布置到生物管腔114内,然后从生物管腔114缩回到管腔壁116刚好阻止压力检查口160内的压力的位置。入口壁保持件口54可另外执行文中所述的压力检查口160的功能。紧线钳布置装置159可具有输送针口161。
图47和48示出处于第二输送构型的紧线钳布置装置159。输送针162可滑动地连接于紧线钳布置装置159。输送针162可在紧线钳布置装置159处于第二输送构型时从输送针口161伸出。
图49和50示出可将紧线钳布置装置159布置到动脉切口120或128内使压力检查口160位于生物管腔114内的位置处。输送针口161可在管腔壁116内或靠近管腔壁116。
图51和52示出可将紧线钳布置装置159置于第二输送构型。如果当紧线钳布置装置159处于第二输送构型时输送针口位于管腔壁116内或靠近管腔壁116,则输送针162可进入管腔壁116。例如,输送针162可进入第二膜142。输送针162可离开第二膜142并如箭头所示进入生物管腔114。
图53示出一推进器164可滑动地连接于输送针162。输送针162可具有针尖孔166。紧线钳100可在输送针162内。可将紧线钳100设置在输送针162内使得紧线钳第一端部102位于推进器164的针尖孔166一侧。
图54示出推进器164可如箭头所示朝针尖孔166移动。输送针162可相对于推进器164后移,推进器164可相对于输送针162前移,或(执行)它们的组合。推进器164可将紧线钳第一端部102推出输送针162。推进器164可将紧线钳第一端部102推进生物管腔114。
图55和56示出紧线钳布置装置159在将紧线钳第一端部102布置到生物管腔114内之后可处于第一缩回构型。当输送针162缩进紧线钳布置装置159内时,紧线钳第二端部104可位于紧线钳布置装置159内。细丝106可延伸通过输送针口161。
图57和58示出紧线钳100可横过管腔壁布置。当从动脉切口中取出紧线钳布置装置159时,紧线钳第二端部104可从输送针口161布置在管腔壁116外部。紧线钳第一端部102可与管腔壁表面118形成干涉配合。紧线钳第二端部104可与管腔壁116的外部或周围组织例如皮下组织形成干涉配合。例如对于图20中所示的紧线钳100,紧线钳第二端部104可滑动地沿细丝106朝管腔壁116平移。细丝106从紧线钳第一端部102(开始)的位于紧线钳第二端部104的相对侧的长度可被切割、折断、撕断或用其它方法去除。
图59到63示出布置紧线钳100的方法。输送针162可如箭头所示从紧线钳布置输送口163伸出。紧线钳布置输送口163可位于输送导向件4内。输送针162可朝管腔114前进。
图60示出可穿过管腔壁布置输送针162。当输送针162穿过管腔壁116布置时,输送针可与第二动脉切口相交或经过第二动脉切口附近。
图61和62示出推进器164可如箭头所示穿过输送针162前进。紧线钳第一端部102可从针尖孔166离开。紧线钳第一端部102可展开到管腔114内。
图63示出如箭头所示,输送针162可缩进输送导向件4内和/或细丝106可被拉紧。紧线钳第一端部102可与管腔壁表面118形成干涉配合。紧线钳第二端部104(图63中未示出)可在细丝106上可滑动地平移到管腔壁116外部,并与其形成干涉配合。细丝106从紧线钳第一端部102(开始)的位于紧线钳第二端部104的相对侧的长度可被切割、折断、撕断或用其它方法去除。
图64示出导引针165,该导引针的一端例如通过使用Seldinger技术如箭头所示穿过管腔壁116并插入管腔114。导引针165可以是空心的和/或具有纵向通道。图65示出导线168可如箭头所示穿过导引针165的空心和/或纵向通道布置。
图66示出可如箭头所示从管腔壁116取出导引针165。导线168可基本上保留在原位。在取出导引针165之后,导线168的一部分可位于管腔114外部,并且导线168的另一部分可位于管腔114内。
图67示出将导线168固定地或可滑动地连接到锚杆6上的方法。可将导线近端170放置于锚杆远端172附近。然后可如箭头所示将导线近端170连接到锚杆远端172。可在一些或全部导线168位于管腔114内的同时将导线近端170连接到锚杆远端172。可将导线近端170构造成卡扣配合、干涉配合、可滑动地连接到锚杆6上或(执行)它们的组合。当将导线168连接到锚杆6上时,导线168可用作锚杆延伸部分14和/或管腔工具。图68示出连接于锚杆6的导线168。
当可应用时,前文所述的用于布置任何辅助封闭装置的方法可用于布置任何其它的辅助布置装置。本领域技术人员可明显地看到,在不脱离本发明的精神和范围的情况下,可对本公开进行各种修改和变型并且可使用等同物。与任何实施例一起示出的部件对于该特定实施例都是示例性的,并且可用于本公开内的其它实施例。

Claims (8)

1.一种用于进入具有管腔壁的生物管腔的装置,所述管腔壁具有纵向管腔壁轴线,所述装置包括:
具有纵向部件轴线的细长部件,其中所述部件构造成以第一角度进入管腔,所述第一角度通过纵向管腔壁轴线和纵向部件轴线限定,所述第一角度小于大约19度。
2.根据权利要求1的装置,其特征在于,所述第一角度小于大约15度。
3.根据权利要求2的装置,其特征在于,所述第一角度小于大约10度。
4.根据权利要求3的装置,其特征在于,所述第一角度大于大约5度。
5.根据权利要求1的装置,其特征在于,所述装置还包括锚杆。
6.根据权利要求5的装置,其特征在于,所述锚杆构造成保持所述细长部件相对于纵向管腔壁轴线成固定角度。
7.根据权利要求1的装置,其特征在于,所述装置还包括保持件。
8.根据权利要求7的装置,其特征在于,所述保持件构造成保持所述细长部件相对于纵向管腔轴线成固定角度。
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